NCT04842838

Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy

Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	paclitaxel DCB	Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.
DEVICE	DES	Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-06-30
• Completion: 2025-06-30
• First posted: 2021-04-13
• Last updated: 2021-04-13

Locations

1 site across 1 country: China